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Effects of Upper Airway Muscle Training on Obstructive Sleep Apnea Severity

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Stanford University

Status

Withdrawn

Conditions

Sleep Apnea

Treatments

Device: Exercise equipment (a musical instrument that is based on the Medical Didgeridoo)

Study type

Interventional

Funder types

Other

Identifiers

NCT04053153
IRB-46406

Details and patient eligibility

About

The purpose of this study is to evaluate the effect of Asate Silent Sleep Training on obstructive sleep apnea (OSA) severity in patients with mild to moderate OSA. The Asate Silent Sleep Training is a muscle strengthening program that uses exercise equipment (a musical instrument that is based on the didgeridoo). The equipment is connected to an application, which provides instruction on how to perform the strengthening exercises, measures the sound produced by the musical instrument, which enables the app to provide feedback on whether the individual should blow less or more and also tracks adherence to the strengthening program.

Sex

All

Ages

21 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age 21 to 50
  • Diagnosed by a physician with mild to moderate OSA, based upon interpretation of data recorded on a take home sleep study
  • Body mass index < 30 kg/m2
  • Mild to moderate OSA, AHI of 5-30

Exclusion criteria

  1. Apnea hypopnea index on overnight sleep study > 30 per hour
  2. Currently practices didgeridoo
  3. Consumes more than 2 alcoholic beverages per day
  4. History of chronic lung disease (e.g., COPD, asthma)
  5. Oral maxillofacial issue or craniofacial musculoskeletal conditions
  6. Any treatment for OSA (current or past)
  7. Mobile device use frequency < once per week
  8. Homelessness
  9. No reliable transportation to assessment sessions
  10. Planned social/family/employment obligations that would limit participant from engaging in Asate Silent Sleep training during the intervention period
  11. Significant upper extremity weakness/paralysis or pain limiting ability to hold the Medical Didgeridoo
  12. Uncorrected low vision or blindness
  13. Deafness
  14. No Internet connection/Chrome browser/mobile devices with iOS and Android
  15. No USB port in computer
  16. Pregnancy

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Triple Blind

0 participants in 2 patient groups

Use of musical instrument
Experimental group
Treatment:
Device: Exercise equipment (a musical instrument that is based on the Medical Didgeridoo)
Use of sham musical instrument
Sham Comparator group
Treatment:
Device: Exercise equipment (a musical instrument that is based on the Medical Didgeridoo)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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